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Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease.

Author: , AfdhalNezam, ArterburnSarah, Brandt-SarifTheo, BrownKimberly, BrownRobert S, CharltonMichael, DenningJill, Dvory-SobolHadas, EversonGregory T, FlammSteven L, FontanaRobert J, FriedMichael W, GilroyRichard, KorenblatKevin M, KumarPrincy, KuoAlexander, KwoPaul, LandisCharles, McHutchisonJohn G, MuirAndrew J, O'LearyJacqueline G, PangPhillip S, PungpapongSurakit, ReddyK Rajender, SchiffEugene, SulkowskiMark S, TepermanLewis, TerraultNorah A, VargasHugo E, WattKymberly D

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

The combination of ledipasvir, sofosbuvir, and ribavirin for 12 weeks produced high rates of SVR12 in patients with advanced liver disease, including those with decompensated cirrhosis before and after liver transplantation.
Paper Details　
Original Abstract of the Article :
BACKGROUND & AIMS: There are no effective and safe treatments for chronic hepatitis C virus (HCV) infection of patients who have advanced liver disease. METHODS: In this phase 2, open-label study, we assessed treatment with the NS5A inhibitor ledipasvir, the nucleotide polymerase inhibitor sofosbuv...See full text at original site
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引用元：
https://doi.org/10.1053/j.gastro.2015.05.010

データ提供：米国国立医学図書館（NLM）

A New Oasis in the Desert of Hepatitis C Treatment

Hepatitis C is a tricky adversary, and when it comes to patients with advanced liver disease, finding effective and safe treatments can feel like searching for water in the middle of the Sahara. This study is a welcome sip of good news, exploring a combination therapy of ledipasvir, sofosbuvir, and ribavirin for patients with HCV genotypes 1 or 4. The researchers used a phase 2, open-label study to assess the effectiveness of this combination, testing it on two cohorts: patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation (Cohort A) and patients who had undergone liver transplantation (Cohort B). Both cohorts were randomly assigned to receive either 12 or 24 weeks of treatment.

The primary endpoint was sustained virologic response at 12 weeks after the end of treatment (SVR12), a measure of how well the treatment cleared the virus from the body. The results were promising: SVR12 was achieved by 86%-89% of patients in Cohort A and by 96%-98% of patients in Cohort B without cirrhosis or with compensated cirrhosis. Even patients with moderate hepatic impairment and fibrosing cholestatic hepatitis showed significant improvement, with SVR12 rates ranging from 60%-75% and 100% respectively. This study found that the combination therapy provided high rates of SVR12 for patients with advanced liver disease, indicating its potential as a valuable weapon in the fight against HCV.

A Glimmer of Hope for Advanced Liver Disease

These findings suggest that this combination therapy could be a valuable tool for treating patients with advanced liver disease, including those with decompensated cirrhosis. This could mean a significant improvement in the quality of life for these patients and potentially slow the progression of their liver disease.

A Sip of Hope for a Healthier Future

This study is a hopeful sign for those battling Hepatitis C. While this therapy is not a cure-all, it does offer a significant improvement in the treatment of advanced liver disease. Further research is needed to evaluate the long-term effects and safety of this combination therapy, but it is an encouraging step in the right direction.

Dr.Camel's Conclusion

This research is a beacon of hope in the vast desert of Hepatitis C treatment. The results show a promising new therapy that could offer a lifeline to those struggling with advanced liver disease. While there is still more research to be done, this study is a significant step towards a healthier future for patients with Hepatitis C.

Date :
  1. Date Completed 2015-11-09
  2. Date Revised 2022-04-09
Further Info :

Pubmed ID

25985734

DOI: Digital Object Identifier

10.1053/j.gastro.2015.05.010

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Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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